TRASTUZUMAB DERUXTECAN for Non-small cell lung cancer

Inclusion criteria

• {"criterion_text":"- At least 18 years of age at the time of signing the informed consent form."}
• {"criterion_text":"- Patient must have histologically or cytologically confirmed metastatic or locally advanced and recurrent NSCLC which is progressing."}
• {"criterion_text":"- Patients eligible for second- or later-line therapy, who must have received an anti PD 1/PD-L1 containing therapy and a platinum-doublet regimen for locally advanced or metastatic NSCLC either separately or in combination. Prior durvalumab is acceptable. The patient must have had disease progression on a prior line of anti PD 1/PD-L1 therapy."}
• {"criterion_text":"- Suitable for a new tumour biopsy. For Module 10 and Module 11 only: If in agreement with the sponsor study physician, a patient may be exempt from a biopsy at pre-screening if a tumour tissue sample is obtained after progression on prior anti-PD-(L)1 therapy and ≤ 3 months prior to pre-screening; a tumour sample taken within the previous 24 months is acceptable if no such sample is available."}
• {"criterion_text":"- ECOG/WHO performance status of 0 to 1, and a minimum life expectancy of 12 weeks."}
• {"criterion_text":"- Patient must have at least 1 lesion that can be accurately measured. A previously irradiated lesion can be considered a target lesion if the lesion has clearly progressed."}
• {"criterion_text":"- Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients."}

Exclusion criteria

• {"criterion_text":"- Patients whose tumour samples have targetable alterations in EGFR and/or ALK at initial diagnosis are excluded. In addition, patients whose tumour samples are known to have targetable alterations in ROS1, BRAF, MET or RET, are to be excluded."}
• {"criterion_text":"- Active or prior documented autoimmune or inflammatory disorders."}
• {"criterion_text":"- Active infection including tuberculosis, hepatitis B (known positive HBV surface antigen [HBsAg] result), hepatitis C, or human immunodeficiency virus (positive HIV 1/2 antibodies)."}
• {"criterion_text":"- Female patients who are pregnant or breastfeeding, or male or female patients of reproductive potential who are not willing to employ effective birth control."}
• {"criterion_text":"- Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients or history of severe hypersensitivity reactions to other monoclonal antibodies."}
• {"criterion_text":"- Patient has spinal cord compression or symptomatic brain metastases."}
• {"criterion_text":"- Any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment. Patients may receive treatment with bisphosphonates or receptor activator of nuclear factor kappa-Β ligand (RANKL) inhibitors for the treatment of bone metastases."}
• {"criterion_text":"- History of active primary immunodeficiency."}

Primary endpoints

• {"endpoint_text":"- Endpoint based on Response Evaluation Criteria in Solid Tumours (RECIST 1.1) Objective response rate (ORR)","definition_or_measurement_approach":"Measured using RECIST 1.1 criteria to evaluate Objective Response Rate (ORR)."}

Secondary endpoints

• {"endpoint_text":"- Overall Survival (OS).","definition_or_measurement_approach":"Overall Survival measured as time from treatment start to death from any cause."}
• {"endpoint_text":"- Endpoints based on RECIST 1.1 including: Disease control rate (DCR)","definition_or_measurement_approach":"Disease Control Rate assessed per RECIST 1.1."}
• {"endpoint_text":"- Endpoints based on RECIST 1.1 including: Best percentage change in tumour size","definition_or_measurement_approach":"Best percentage change in target lesion size measured per RECIST 1.1."}
• {"endpoint_text":"- Endpoints based on RECIST 1.1 including: Duration of response (DoR)","definition_or_measurement_approach":"Duration of Response measured per RECIST 1.1."}
• {"endpoint_text":"- Endpoints based on RECIST 1.1 including: Progression free survival (PFS).","definition_or_measurement_approach":"Progression Free Survival assessed per RECIST 1.1."}

Spain

Earliest CTIS Part Ii Submission Date

04-07-2024

Latest Decision Or Authorization Date

09-08-2024

Processing Time Days

36

Number Of Sites

4

Number Of Participants

36

France

Earliest CTIS Part Ii Submission Date

04-07-2024

Latest Decision Or Authorization Date

14-05-2025

Processing Time Days

314

Number Of Sites

3

Number Of Participants

69

Austria

Earliest CTIS Part Ii Submission Date

04-07-2024

Latest Decision Or Authorization Date

16-05-2025

Processing Time Days

316

Number Of Sites

2

Number Of Participants

43

Germany

Earliest CTIS Part Ii Submission Date

04-07-2024

Latest Decision Or Authorization Date

15-05-2025

Processing Time Days

315

Number Of Sites

1

Number Of Participants

24

Primary sponsor

Full Name

AstraZeneca AB

Organisation Type

Pharmaceutical company

Country Of Registered Address

Sweden

Contract research organisations

Name

Parexel International (IRL) Limited

Responsibilities

Sponsor duties codes 1 and 5; contact Clinicaltrial.Enquiries@parexel.com; phone 035314739500

Third parties

• {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"sponsorDuties codes: 1,5; contact Clinicaltrial.Enquiries@parexel.com","organisation_type":"Pharmaceutical company"}